- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065334
Exercise Training as Medicine for Substance Use Disorder Patients
January 11, 2023 updated by: St. Olavs Hospital
Effects of Low- Versus High Dose High Intensity Interval Training and Strength Training on Physical Health in Substance Use Disorder Patients: A Randomized Controlled Trial
This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients.
The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks.
The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity.
The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload.
It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Henrik Loe, phd
- Phone Number: 0047 92093611
- Email: henrik.loe@stolav.no
Study Contact Backup
- Name: Grete Flemmen, phd
- Email: grete.flemmen@stolav.no
Study Locations
-
-
-
Trondheim, Norway
- Recruiting
- Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital
-
Contact:
- Henrik Loe, phd
- Email: henrik.loe@stoloav.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being an inpatient at the clinic
- Free of known cardiovascular disease, pulmonary disease and cancer
Exclusion Criteria:
- Not able to perform a maximal treadmill test
- Not able to perform a maximal strength test in hack squat
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low dose training
|
1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat
|
Active Comparator: high dose training
|
4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in oxygen uptake
Time Frame: baseline to 8 weeks
|
cardiopulmonary exercise test (CPET) objective gas measurements
|
baseline to 8 weeks
|
change in leg muscular strength
Time Frame: baseline to 8 weeks
|
One repetition maximum strength test half squat
|
baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Kristin Smedsrud, St. Olavs Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
August 21, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
January 12, 2023
Last Update Submitted That Met QC Criteria
January 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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